Roxadex
Dexamethasone
Dosage Form: InjectionPack Size: 5x3x1 ml
Composition:
Roxadex Injection: Each ml sterile aqueous solution contains Dexamethasone Sodium Phosphate USP 5 mg.
Roxadex 6 Injection: Each ml sterile aqueous solution contains Dexamethasone Sodium Phosphate USP equivalent to Dexamethasone 6 mg
Roxadex 6 Tablet: Each tablet contains Dexamethasone BP 6 mg
Dexamethasone is a synthetic glucocorticoid with a high anti-inflammatory potency. It also has anti-allergic, antitoxic, antishock, antipyretic and immunosuppressive properties. Dexamethasone decreases inflammation by acting within cells to prevent the release of certain chemical that are important in the immune system.These chemicals are normally involved in producing immune and allergic responses. Dexamethasone also decreases the numbers of white cells circulating in the blood
Pharmacokinetics:
The biological half-life of Dexamethasone in plasma about 190 minutes. Binding of Dexamethasone to plasma proteins is less than most other corticosteroids and is estimated to be about 77% up to 65% of a dose is excreted in the urine in 24 hours, the rate of excretion being increased following concomitant administration of phenytoin. Dexamethasone, appear to cross the placental barrier with minimal inactivation.
Indications:
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal alIergic rhinitis,and serum sickness. Collagen disease: Like lupus erythematosus,rheumatoid arthritis etc. Dermatologic diseases: Bullous dermatitis herpetiformis,exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrinedisorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis. Gastrointestinal diseases: Regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia),idiopathic thrombocytopenic purpura in adults, pure red cell aplasia and selected cases of secondary thrombocytopenia. Neoplastic diseases: Leukemias and lymphomas. Nervous system. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis,fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias,symptomatic sarcoidosis. Rheumatic disorders: As adjunct e therapy for short-term administration (to tide the pat t ov acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial invoIvement,tubercuIous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
Dosage & Administration:
In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. If no favorable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.
For tablet:
1. In adult patients, daily oral dosages vary from 1 mg to 10 mg and children from 0.03-0.20 mg/kg body weight, according to the individual response.
2. In some patients higher dosages may be temporarily required, to control the disease. As soon as circumstances permit, dosage should be decreased.
3. For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasma cortisol measured the next morning. Patients who do not show a decrease in cortisol can be exposed to a longer test:0.5 mg dexamethasone is given at 6-hour intervals for 48 hours aollowed by 2 mg every 6 hours for further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17 alpha-hydroxycorticoids. 6 mg tablet once daily for 7-10 days as per WHO guidelines.
For injection:
Dexamethasone can be given by intraveneous (IV), intramuscular (IM) or local injection. Dexamethasone injections can also be diluted with a infusion fluid or be injected directly into the infusion line. Intravenous injections of massive doses should be given slowly, over a period of several minutes.lntramuscular administration should be given by deep intramuscular injection,to prevent atrophy of the subcutaneous adipose tissues. Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. When diluted with these infusion fluids, Dexamethasone will keep its potency for at least 24 hours (at room temperature and in daylight conditions). As infusion fluids, Sodium chloride 0.9%, Anhydrous glucose 5%, Invert sugar 10%,Sorbitol 5%, Ringer's solution, Hartman‘s solution (Ringer-lactate) etc. can be patients. For systemic therapy in adults, daily doses of 0.05-0.20 mg/kg body weight are usually sufficient. For emergencies (e.g. anaphylaxis, acute sever asthma, cerebral edema) substantially higher doses are required. An initial dose of 10-20 mg IV is followe by 6 mg IV or IM every 6 hours, until a satisfactory result has been obtained.Thereafter the dosage has to be tapered off gradually. For local therapy, the following doses are recommended: Intra-articularly 2-4 mg in large and 0.8-1 mg in small joints. lntrabursalIy: 2-4 mg, in tendon sheaths: 0.4-1 mg. The frequency of these injections may vary from every 3-5 days to every 2-3 weeks. 6 mg injection once daily for 7-10 days as per WHO guidelines.
Contraindications:
Gastric and duodenal ulcers
• Systemic and ophthalmic fungal infections
• Viral infections, e.g. varicella and herpes genitalis infections.Viral infections of the eye
• Glaucoma
• Hypersensitivity to corticosteroids
Warning & Precautions:
General: The lowest possible dose of corticosteroids should be used to control the condition under treatment. The reduction should be gradual. Cardio-renal. These agents should be used with caution in patients with congestive heart failure, hypertension,or renal insufficiency.
Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. Gastrointestinal. Steroids should be used with caution in active or latent peptic ulcers, diverticuIitis,fresh intestinal anastomoses,and nonspecific ulcerative coIitis,since they may increase the risk of a perforation.
Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.
Overdose:
Overdosage is unlikely, however treatment of overdosage is by supportive and symptomatic therapy.
Storage Conditions:
Roxadex Tablet: Store below 250 C, frost free & dry place. Keep away from light and out of the reach of children. Roxadex Injection: Store below 300 C. & frost free place. Keep away from light and out of the reach of children.
Commercial Pack:
Roxadex Injection: Each box contains 5x3x1 ml ampoules in alu-pvc blister strip.
Roxadex 6 Injection: Each box contains 10x1 ml ampoules in alu-pvc blister strip.
Roxadex 6 Tablet: Each box contains 3x10 tablets in blister pack.